Henry Schein Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to HSIC.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 18Class IIJul 9, 2026Specific lots were distributed in the US with incorrect pack	Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S.	Class IIDevices	Jul 9, 2026
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179,Class IIJul 9, 2026Specific lots were distributed in the US with incorrect pack	Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S.	Class IIDevices	Jul 9, 2026